BRONCOMAR- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Broncomar by

Drug Labeling and Warnings

Broncomar by is a Otc medication manufactured, distributed, or labeled by Gadal Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acvtive ingredients: (in 10 ml)              Purpose

Acetaminophen 200 mg ............................. Analgesic

Dextromethorphan HBr 13.33 mg ................... Cough Suppressant

Guaifenesin 200 mg ................................... Expectorant

Phenylephrine HCl 5 mg ............................. Decongestant

PURPOSE

Purpose

Analgesic

Cough Suppressant

Expectorant

Decongestant

INDICATIONS & USAGE

Uses

• For temporary relief of bronchial and nasal congestion
• Help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
• Teporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold

WARNINGS

Warnings

Do not exceed recommended dosage

Liver warning: This product contains Acetaminophen. Sever liver damage may occur if

• Adult takes more than 6 doses in 24 hours, which is the maximum daily amount
• Child takes more than 5 doses in 24 hours
• Taken with other drugs containing Acetaminophen
• Adult has 3 or more alcoholic drinks everyday while using this product
• Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician

DO NOT USE

Do not use

• If you are now taking a prescription monoamine oxidase inhibitor (MAOI)( certain drugs for depression , psychiatric conditions, or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug.
• if you do not know if your prescription drug contains on MAOI ask your doctor or pharmacist before taking this product
• if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor
• avoid alcoholic beverages while you are taking this product
• do not use with any other drug containing Acetaminophen (prescirption or nonprescription). If you are not sure whether a drug contains Acetaminophen, ask a doctor or a pharmacist.

Ask the doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
• heart disease, high blood pressure, thyroid disease, or difficulty in urination due to the enlargement of prostate gland.
• The user has liver disease
• The user is taking the blood thinning drug Warfarin.

STOP USE

Stop use and ask the doctor if

• Nervoisness, dizziness or sleeplessness occurs.
• Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be sign of a serious condition

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use. 

 

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Do not take more than 6 doses in any 24-hour period

Age                                                                        Dose

Adults and children 12 years and over           10 mL (2 tsps) every 6 hours

Children 6 to under 12 years of age.               5 mL (1 tsps) every 6 hours

Children under 6 years of age                       Do not use

INACTIVE INGREDIENT

Inactive ingredients

Aloe vera, citric acid, disodium EDTA, FD&C Red #40, hydroxyethyl cellulose, natural strawberry flavor, propylene glycol, water, sodium benzoate, sorbitol 70%, sucralose

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRONCOMAR 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-215
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	13.33 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53113-215-06	1 in 1 CARTON
1		177 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/01/2014

Labeler - Gadal Laboratories Inc (841305639)